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Antares Pharma, Inc. (NASDAQ:ATRS) today announced that a meeting was held with the U.S. Food and Drug Administration (FDA) to discuss a registration study for the VIBEX QuickShot auto injector in testosterone deficient adult males. The study will include approximately 150 adult males with testosterone blood levels less than 300 ng/dL, and will begin recruitment in the third quarter of 2014. The study is designed to show that once-weekly self-administration of testosterone with the VIBEX QuickShot auto injector can safely achieve normal blood levels of testosterone in hypogonadal men.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are very optimistic about the potential for a self-administered, once-weekly subcutaneous dose of testosterone based on the discussions we had with the FDA.” Dr. Wotton continued, “We are committed to working closely with the FDA on all aspects of the study and believe that we will be able to provide a novel product for self-administration of testosterone at home that offers a new and potentially safer route of administration than currently available options for treating hypogonadism or Low T.”
About QuickShot Auto Injector
The proprietary VIBEX QuickShot auto injector emphasizes enhanced performance on the attributes contributing most to patients successfully controlling their testosterone deficiency – reliable and consistent blood levels, ease and speed of self-administration, comfort and discretion. The State-of-the-Art precision engineering of the QuickShot device allows rapid subcutaneous self-administration of highly viscous drugs such as testosterone and biologics using high spring pressure through a fine gauge needle. Conventional auto injectors or even a vial, needle and syringe could not inject these drugs efficiently or as fast and easy as the QuickShot device.
About Testosterone Deficiency
Testosterone deficiency, also known as male hypogonadism or Low T, is a condition in which the body doesn’t produce enough testosterone – the hormone that plays a key role in masculine growth and development during puberty, and maintenance of musculoskeletal and mental health in maturity. Symptoms of male hypogonadism can be treated with testosterone replacement therapy. According to published data, 2013 U.S. sales of testosterone replacement therapies were approximately $2.8 billion dollars with prescriptions on average growing more than 20% annually.